Csv Consultant

2 weeks ago

Mumbai, India Infocus Technologies Full time

Job Title: Computer System Validation (CSV) Specialist

Location: Mumbai
Experience: 4 to 6 years

Job Description:

We are looking for a skilled CSV Professional with 46 years of experience in validating enterprise systems, particularly SAP S/4 HANA and MDG. The ideal candidate will also have working knowledge of regulatory compliance frameworks and tools such as TrackWise, LIMS, 21 CFR Part 11, and EU Annex 11.

Key Responsibilities:

  • Perform Computer System Validation (CSV) activities for enterprise systems like SAP S/4 HANA and Master Data Governance (MDG)
  • Prepare and review validation deliverables: URS, FS, DS, IQ, OQ, PQ, Traceability Matrix, etc.
  • Ensure systems comply with 21 CFR Part 11, EU Annex 11, and other GxP requirements
  • Participate in audits and support regulatory inspection readiness
  • Collaborate with cross-functional teams including IT, QA, and Business
  • Support validation activities for TrackWise, LIMS, and other GxP systems

Primary Skills (Mandatory):

  • CSV for Enterprise Systems (SAP S/4 HANA, MDG)

Secondary Skills (Preferred):

  • TrackWise
  • LIMS
  • 21 CFR Part 11
  • EU Annex 11

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